Genome Diagnostics Pvt. Ltd.
An ISO 13485 : 2003 & ISO 9001 : 2000 Certified Company / CE Marked Real Time PCR Kits.

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June 16, 2010
H1N1 Real Time PCR Kits Technology for Sale

Emergo Regulatory

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International Regulatory Compliance Information

This is a sample web page that shows how you could display your company's international regulatory compliance information. Having a dedicated regulatory compliance page is useful to prospective customers, end users, distributors and regulatory officials. Please note that while the information you post is not confidential, it does make it more readily accessible to your competitors. Keep this in mind if there is any question regarding the classification of your devices or if you would prefer not to disclose the regulatory information that could be obtained from the documents.

Most links shown below do not function and are for illustration purposes only.


QUALITY MANAGEMENT SYSTEM

ISO 13485 quality system certification (PDF format)

ISO 13485:2003 certificate

 


PRODUCT CERTIFICATIONS AND APPROVALS

EUROPE - CE Marking certificates(PDF format)

Device 1 | Device 2 | Device 3 | Device 4

EUROPE - Declarations of Conformity (PDF format)

Device 1 | Device 2 | Device 3 | Device 4

INDIA -


GLOBAL REGULATORY REPRESENTATIVES

Shown below are our in-country representatives for regulatory affairs issues and incident reporting. For a list of our distributors worldwide, please click here. NOTE: Emergo is listed as the representative for all regions below. You should, of course, list the appropriate representative for your company in each region.

EUROPE - Authorized Representative

Emergo Europe, The Hague, NETHERLANDS

Telephone: +31.70.345.8570

http://www.EmergoGroup.com


NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY

Genome Diagnostics Pvt. Ltd. maintains ISO 13485:2003 certification and is audited every year by:

 

AAA Auditing Services

Anytown, USA

Telephone: +1.555.555.1234

Website link


MATERIAL SAFETY DATA SHEETS

Device 1 | Device 2 | Device 3 | Device 4

CONTACT US

 
Geno Sen's is a registered Trademark of Genome Diagnostics Pvt. Ltd. India. 2008 Genome Diagnostics Pvt. Ltd. All Rights Reserved